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Janssen Spa represents the pharmaceutical sector of the Johnson & Johnson group and markets over 30 medicinal specialties pertaining to five different therapeutic areas with the aim of offering groundbreaking therapeutic solutions that meet high standards of efficacy and safety.
For the production site of Borgo San Michele (Latina) we are looking for an Associate Analyst QC to be hired in the Quality Control Department with a permanent contract. The profile will work in the Lab Support (LS) team and the main responsibilities will be:
- Support the equipment introduction activities in agreement with the strategy defined with the ELM supervisor
- Support the definition of the C&Q (Commissioning and Qualification) strategy for the analytical equipment
- Prepare the relevant documentation for the analytical equipment introduction and qualification (URS, protocols, exc)
- Execute the protocols for the analytical equipment introduction and qualification
- Collaborate in a multidisciplinary team for the analytical equipment introduction to guarantee:
- The adherence of the systems to the current pharmaceutical regulations (eg.: pharmacopeia, CFR21 part 11, …)
- The adherence to the DI and ALCOA of the equipment SOP
- Support and execute the activities for QC Software application updating and life cycle management
- Connect with the global ELM functions
- Support the implementation of local remediation and innovation initiatives
- Support the direct Supervisor in the management of the priorities and the group activities
- Collaborate with the Engineering and EHS departments to support the equipment introduction strategy
- Supervise and control the external contractors that perform C&Q activities
- Support the supervisor during GMP audits (Internal and External)
- Support the preparation laboratory procedures issuing
- Master's Degree in Engineering, Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biology or equivalent titles
- Proficiency in English (Be level and above)
- At least 3 years of experience in the pharmaceutical environment
- At least 2 years of experience in equipment qualification/software validation
- Project management skills will be considered a plus
- Capability to work in multidisciplinary environment with the attitude to teamwork
- Good knowledges on Empower 3
- Laboratory IT system knowledges will be considered a plus
- Good knowledge of the office package
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin and will not be discriminated against on the basis of diversity.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in Italy are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!